Company · CN
Promisemed Hangzhou Meditech Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2026. Name variants (Inc, Corp, punctuation) are merged.
36510(k) clearances (5 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 13 |
| FMF | Syringe, Piston | 7 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 5 |
| KNW | Instrument, Biopsy | 3 |
| PTI | Non-Coring (Huber) Needle | 3 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 |
| MMK | Container, Sharps | 1 |
| PKL | Hemostatic Metal Clip For The Gi Tract | 1 |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 25, 2026 | K261719 | Promisemed X-Safety Pen Needle Promisemed Hangzhou Meditech Co., Ltd., CN | FMI |
| May 12, 2026 | K261196 | Promisemed VeriEcto Automatic Biopsy Needles Promisemed Hangzhou Meditech Co., Ltd., CN | KNW |
| May 1, 2026 | K261045 | Verifine Safety Lancets Promisemed Hangzhou Meditech Co., Ltd., CN | FMK |
| Apr 16, 2026 | K254273 | Verisafe Safety Sterile Needles (SSN) Promisemed Hangzhou Meditech Co., Ltd., CN | FMI |
| Dec 10, 2025 | K250192 | Verisafe Safety Retractable Insulin Syringes Promisemed Hangzhou Meditech Co., Ltd., CN | FMF |
| Jun 4, 2025 | K250961 | Blood collection tube holders Promisemed Hangzhou Meditech Co., Ltd., CN | JKA |
| May 13, 2025 | K251138 | Promisemed Safety Huber Needles Promisemed Hangzhou Meditech Co., Ltd., CN | PTI |
| Mar 14, 2025 | K243332 | Promisemed Safety Huber Needles Promisemed Hangzhou Meditech Co., Ltd., CN | PTI |
| Jan 10, 2025 | K243806 | Safety Winged Blood Collection Sets Promisemed Hangzhou Meditech Co., Ltd., CN | FMI |
| Oct 4, 2024 | K240675 | Endoscopic Injection Needles Promisemed Hangzhou Meditech Co., Ltd., CN | FBK |
| Sep 26, 2024 | K242632 | Verifine® Pen Needles Promisemed Hangzhou Meditech Co., Ltd., CN | FMI |
| Jul 12, 2024 | K234124 | Single Use Hemoclips Promisemed Hangzhou Meditech Co., Ltd., CN | PKL |
| Sep 28, 2023 | K231792 | VeriSafe Safety sterile syringes Promisemed Hangzhou Meditech Co., Ltd., CN | FMF |
| Jun 8, 2023 | K230715 | Promisemed Safety Huber Needle Promisemed Hangzhou Meditech Co., Ltd., CN | PTI |
| Mar 2, 2023 | K223453 | Insulin Syringe Promisemed Hangzhou Meditech Co., Ltd., CN | FMF |
| Feb 21, 2023 | K223643 | Verifine® Ease Lancing Device, Verifine® Lancing Device Promisemed Hangzhou Meditech Co., Ltd., CN | QRL |
| Feb 15, 2023 | K222271 | Verisafe Safety sterile needles Promisemed Hangzhou Meditech Co., Ltd., CN | FMI |
| Sep 19, 2022 | K220129 | Promisemed X-Safety Pen Needle Promisemed Hangzhou Meditech Co., Ltd., CN | FMI |
| Jun 9, 2022 | K221368 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet Promisemed Hangzhou Meditech Co., Ltd., CN | FMK |
| Jun 8, 2022 | K221371 | Promisemed Heel Blood Lancet Promisemed Hangzhou Meditech Co., Ltd., CN | FMK |
| Apr 22, 2022 | K213683 | Promisemed Fine Biopsy Needle Promisemed Hangzhou Meditech Co., Ltd., CN | KNW |
| Apr 5, 2022 | K213560 | Verifine Safety Syringe with Fixed Needle Promisemed Hangzhou Meditech Co., Ltd., CN | FMF |
| Nov 17, 2021 | K211890 | Promisemed Sharps container Promisemed Hangzhou Meditech Co., Ltd., CN | MMK |
| Sep 9, 2021 | K211242 | Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes Promisemed Hangzhou Meditech Co., Ltd., CN | FMF |
| Sep 8, 2021 | K210712 | Verifine Mechanical Safety Insulin Syringe Promisemed Hangzhou Meditech Co., Ltd., CN | FMF |
| Aug 12, 2021 | K210946 | Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles Promisemed Hangzhou Meditech Co., Ltd., CN | KNW |
| Jul 21, 2021 | K210059 | Promisemed Insulin Pen Needle Promisemed Hangzhou Meditech Co., Ltd., CN | FMI |
| Jun 25, 2021 | K211293 | Safety Winged Blood Collection Sets Promisemed Hangzhou Meditech Co., Ltd., CN | FMI |
| Apr 22, 2021 | K210065 | Verifine Safety Type Insulin Pen Needle Promisemed Hangzhou Meditech Co., Ltd., CN | FMI |
| Jan 5, 2021 | K193273 | Insulin Syringe Promisemed Hangzhou Meditech Co., Ltd., CN | FMF |
| Dec 31, 2020 | K202681 | Promisemed Covered Safety Pen Needle Promisemed Hangzhou Meditech Co., Ltd., CN | FMI |
| Nov 24, 2020 | K202682 | Promisemed Triple Safety Pen Needle Promisemed Hangzhou Meditech Co., Ltd., CN | FMI |
| Dec 3, 2019 | K193009 | Promisemed Heel Blood Lancet Promisemed Hangzhou Meditech Co., Ltd., CN | FMK |
| Dec 2, 2019 | K192666 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet Promisemed Hangzhou Meditech Co., Ltd., CN | FMK |
| Sep 5, 2019 | K191853 | Dual-Safety Pen Needle Promisemed Hangzhou Meditech Co., Ltd., CN | FMI |
| May 11, 2017 | K161950 | Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle Promisemed Hangzhou Meditech Co., Ltd., CN | FMI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||